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IRE BRD: List of Tables
March 2006
LIST OF TABLES
Table 1-1
Table 1-2
Table 2-1
Table 2-2
Table 2-3
Table 3-1
Table 3-2
Table 4-1
Table 4-2
Table 4-3
Table 4-4
Table 4-5
Table 4-6
Table 6-1
Table 6-2
Table 6-3
Table 6-4
Table 6-5
Table 6-6
Summary of Current U.S. Legislation Related to Ocular Health ..................1-2
In Vivo Ocular Irritancy Classification Systems...........................................1-5
Evaluation of Corneal Irritation................................................................. 2-10
Fluorescein Penetration Scoring System.................................................... 2-12
Overall Scoring System for Corneal Damage and Irritation… ................... 2-13
Chemical Classes Tested in the IRE Test Method........................................3-4
Product Classes Tested in the IRE Test Method ..........................................3-4
Scale of Weighted Scores for Grading the Severity of Ocular
Lesions .......................................................................................................4-2
Test Guidelines for In Vivo Ocular Irritation Test Methods .........................4-4
Criteria for Classification of Rabbits According to the GHS
Classification System................................................................................ 4-11
Criteria for Classification of Substances According to the GHS
Classification System (Modified from UN 2003). ..................................... 4-12
Criteria Required for Classification of Rabbits According to the EPA
Classification System (EPA 1996). ........................................................... 4-13
Criteria for Classification of Substances According to the EU
Classification System (EU 2001) .............................................................. 4-13
Evaluation of the Performance of the IRE Test Method In Predicting Ocular Corrosives and Severe Irritants Compared to the In Vivo
Rabbit Eye Test Method, as Defined by the GHS Classification
System, by Study .......................................................................................6-5
False Positive and False Negative Rates of the IRE Test Method,
by Chemical Class and Properties of Interest, for the GHS
Classification System (Analysis Based on the
Expanded Data Set) ...................................................................................6-7
False Positive and False Negative Rates of the IRE Test Method
by Chemical Class and Properties of Interest, for the GHS
Classification System (Analysis Based on the Pooled Data Set) ..................6-9
Evaluation of the Performance of the IRE Test Method in Predicting
Ocular Corrosives and Severe Irritants Compared to the In Vivo
Rabbit Eye Test Method, as Defined by the EPA Classification
System, by Study ...................................................................................... 6-11
False Positive and False Negative Rates of the IRE Test Method,
by Chemical Class and Properties of Interest, for the EPA
Classification System (Analysis Based on the Expanded Data
Set) .........................................................................................................6-13
False Positive and False Negative Rates of the IRE Test Method,
by Chemical Class and Properties of Interest, for the EPA
Classification System (Analysis Based on the
Pooled Data Set) ......................................................................................6-14
viii
IRE BRD: List of Tables
Table 6-7
Table 6-8
Table 6-9
Table 7-1
Table 7-2
Table 7-3
Table 7-4
Table 7-5
Table 7-6
Table 7-7
Table 9-1
Table 9-2
Table 9-3
Table 9-4
Table 9-5
Table 9-6
Table 9-7
March 2006
Evaluation of the Performance of the IRE Test Method in Predicting
Ocular Corrosives and Severe Irritants Compared to In Vivo
Findings, as Defined by the EU Classification
System, by Study .....................................................................................6-16
False Positive and False Negative Rates of the IRE Test Method,
by Chemical Class and Properties of Interest, for the EU
Classification System (Analysis Based on the Expanded Data
Set) ..........................................................................................................6-19
False Positive and False Negative Rates of the IRE Test Method,
by Chemical Class and Properties of Interest, for the EU
Classification System (Analysis Based on the
Pooled Data Set) ......................................................................................6-20
Interlaboratory Variability of Balls et al. (1995) for Substances
Classified as Ocular Corrosives/Severe Irritants or Nonsevere Irritants/
Nonirritants Using the GHS Classification System…………………………7-4
Interlaboratory Variability of Balls et al. (1995) for Substances
Classified as Ocular Corrosives/Severe Irritants or Nonsevere
Irritants/Nonirritants Using the EPA Classification System ....................... 7-5
Interlaboratory Variability of CEC Collaborative Study (1991)
for Substances Classified as Ocular Corrosives/Severe
Irrittants or Nonsevere Irritants/Nonirritants Using the EU
Classification System ................................................................................ 7-7
Interlaboratory Variability of Balls et al. (1995) for Substances
Classified as Ocular Corrosives/Severe Irritants or Nonsevere
Irritants/Nonirritants Using the EU Classification System ..................……7-8
Quantitative Evaluation of the Interlaboratory Variability of the IRE
Test Method (CEC 1991). ........................................................................7-11
Quantitative Evaluation of the Interlaboratory Variability of the IRE
Test Method (Balls et al. 1995) .................................................................7-13
Interlaboratory Correlation Ranges Determined for Various
Subsets of Tested Substances in Balls et al. (1995)....................................7-18
In Vitro/In Vivo Correlation Coefficients from Balls et al. (1995)................9-3
Relationship Between MAS In Vitro and the Ability to Cause More
Than 15% Corneal Swelling In vitro (Chamberlain et al. 1997)...................9-4
Comparison of IRE Test Method Results With In Vivo Data
(Cooper et al. (2001). ................................................................................ 9-4
The Results of the CTFA Evaluation of In Vitro Alternatives to the Draize
Primary Eye Irritation Test (Phase III): Surfactant-Based Formulations
(Gettings et al. 1996)................................................................................. 9-5
Comparison of IRE In Vitro Irritancy Grades to In Vivo Rabbit
Eye Test Irritancy Classifications (Koëter and Prinsen 1985)..................... 9-9
Irritancy of Surfactant-Based Products Using P&G In Vivo
and ExRET In Vitro Confocal Microscopy Test Methods. ........................9-15
Irritancy of General Chemicals Using P&G In Vivo and ExRET In Vitro Confocal Microscopy Test Methods................................9-16
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IRE BRD: List of Tables
Table 9-8
Table 9-9
March 2006
Irritancy of Surfactant-Based Liquid Dishwashing Formulations
Using LVET and Histopathology In Vivo and P&G ExRET
Confocal Microscopy In Vitro Test Method .............................................9-17
Irritancy of Bleach-Containing Laundry Additive Products
Using LVET In Vivo and P&G ExRET In Vitro Confocal
Microscopy Test Methods........................................................................9-17
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